Who else makes this device?

Name: The Vest APX System
Brand: The Vest APX System

Anesthesiology › TherapeuticPercussor, Powered-Electric

The Vest APX System

The Vest APX Control Unit (High Frequency Chest Wall Oscillation Device)

Registry build 21.09.26

1manufacturer

3catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

Registered in Chongqing.

Chinese manufacturers registered for FDA product code BYI
Manufacturer	City	Province	Registered as	Device types
Chongqing Sonmol Technology Co., Ltd.	Chongqing	Chongqing	Contract manufacturer	9

Record

Regulatory record for The Vest APX System
Listed by	Hill-Rom Services Pte, Ltd., Singapore
FDA product code	BYI
Device type	Percussor, Powered-Electric
Device class	Class 2
Regulation	21 CFR 868.5665
Record published	2024-09-06

Specifications

Specifications
MRI safety	MR Unsafe
Single use	Yes
Label carries	manufacturing date, serial number
Storage	Storage environment temperature -25 to 70 °C; Storage environment humidity 10 to 90 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal

Catalogue Numbers

Catalogue numbers for The Vest APX System
Catalogue number	Size	Status
M08463		In distribution
M08368		In distribution
M08367		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
G5®	General Physiotherapy, Inc.	354
InCourage®	Respiratory Technologies, Inc.	252
SmartVest	Electromed, Inc.	172
The Vest®System	Hill-Rom Services Pte, Ltd.	97
AffloVest	Tactile Systems Technology Inc	39
ClearChest®	Respiratory Technologies, Inc.	31
AffloVest	Movair, Inc.	7
Portex	ICU Medical, Inc	4
Vibralung®	Westmed, Inc.	3
Frequencer	Dymedso, Inc.	3
Vibralung Patient Kit	Westmed, Inc.	2
Monarch™ System	Hill-Rom Services Pte, Ltd.	2

Showing 12 of 34. All products under Percussor, Powered-Electric

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K163378	2017-03-17

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.